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Details with Side Effects
Distribution Program For LUMIZYME®
Patients and caregivers should be informed that LUMIZYME is available only under a restricted distribution program called the LUMIZYME ACE (Alglucosidase Alfa Control and Education) Program.
The purpose of the program is to ensure that the known risks of anaphylaxis and severe allergic reactions and the potential risks of severe cutaneous and systemic immune mediated reactions associated with the use of LUMIZYME are communicated to patients, caregivers, and prescribers. In addition, the purpose of the program is to mitigate the potential risk of rapid disease progression in infantile-onset Pompe disease patients and late (non-infantile) onset Pompe disease patients less than 8 years of age with for whom the safety and effectiveness of LUMIZYME have not been evaluated.
Patients and caregivers should also be informed that only trained and certified prescribers, and healthcare facilities enrolled in the program are able to prescribe, dispense or administer LUMIZYME, and that patients must be enrolled in and meet all the conditions of the LUMIZYME ACE Program to receive LUMIZYME.
Patients and their caregivers should be informed that a registry for patients with Pompe disease (the Pompe Registry) has been established in order to better understand the variability and progression of Pompe disease, and to continue to monitor and evaluate long-term treatment effects of LUMIZYME. The Pompe Registry will also monitor the effect of LUMIZYME on pregnant women and their offspring [see Use In Specific Populations]. Patients and their caregivers are encouraged to participate in the Pompe Registry and advised that their participation is voluntary and may involve long-term follow-up. For more information regarding the registry program visit www.pomperegistry.com or by calling 1-800-745-4447.
Patients and caregivers should be informed that the most common adverse reactions observed with LUMIZYME were infusion reactions. Infusion reactions may occur during or within 2 hours after completion of the infusion. Symptoms associated with infusion reactions include urticaria, diarrhea, vomiting, dyspnea, pruritus, rash/erythema, pharyngolaryngeal pain, neck pain, hypoacusis, flushing/feeling hot, pain in extremity, fall, and chest discomfort, respiratory distress, cough, livedo reticularis, agitation, irritability, retching, rigors, tremor and increased lacrimation.
Last reviewed on RxList: 7/14/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Lumizyme Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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